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Phase III

A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)

  • Study HIC#:2000028219
  • Last Updated:10/22/2021

The purpose of this study is to compare the effects, good or bad, of Obinutuzumab versus placebo on patients with lupus nephritis. Obinutuzumab is a monoclonal antibody that targets a type of white blood cells known as a B cell and is an approved drug for certain types of blood cancers.  This study will help determine if using Obinutuzumab to reduce B cells will improve the signs and symptoms of lupus nephritis. If you meet the study requirements and are enrolled, you will be in this study for about 76 weeks.

  • Age18 years - 75 years
  • GenderBoth
  • Start Date09/14/2021
  • End Date10/06/2023

Trial Purpose and Description

The purpose of this study is to compare the effects, good or bad, of Obinutuzumab versus placebo on patients with lupus nephritis. Obinutuzumab is a monoclonal antibody that targets a type of white blood cells known as a B cell and is an approved drug for certain types of blood cancers.  This study will help determine if using Obinutuzumab to reduce B cells will improve the signs and symptoms of lupus nephritis. If you meet the study requirements and are enrolled, you will be in this study for about 76 weeks.

Eligibility Criteria

Key Inclusion Criteria:

  • Diagnosis of active or active/chronic ISN/RPS 2003 Class III or IV proliferative LN as evidenced by renal biopsy performed within 6 months. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease
  • Urine protein to creatinine ratio greater than or equal to (>/=) 1 on a 24-hour collection
  • Other inclusion criteria may apply

Key Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Severe renal impairment or the need for dialysis or renal transplantation
  • Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
  • Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation
  • Known active infection of any kind or recent major episode of infection
  • Intolerance or contraindication to study therapies
  • Other exclusion criteria may apply

Principal Investigator

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